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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFlexAbility and FlexAbility SE Ablation Catheter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantAbbott Medical
2375 MORSE AVENUE
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS076
Date Received04/19/2021
Decision Date05/18/2021
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH.
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